The correlation between GDPR and HIPAA is more significant than most organizations realize.
Although born out of different needs and jurisdictions, these two monumental regulations share common ground in their goal to protect sensitive data.
Yet, they also diverge in key areas that can create a labyrinth of compliance requirements for businesses operating across borders.
Understanding these similarities and differences is not just a matter of legal obligation—it’s a strategic imperative.
Understanding GDPR and HIPAA
To fully appreciate the correlation between GDPR and HIPAA, it’s essential first to understand each regulation’s origins, scope, and objectives.
GDPR Overview
The General Data Protection Regulation (GDPR) is a sweeping data protection law enacted by the European Union in 2018.
It represents one of the most stringent privacy laws globally, giving individuals greater control over their data.
The GDPR applies to any organization, regardless of location, that processes the personal data of EU citizens.
This means that a company in the United States, China, or anywhere else in the world is subject to GDPR if it handles the data of EU residents.
The key objectives of GDPR include ensuring transparency in how personal data is used, enhancing data security measures, and providing individuals with rights such as the right to access, correct, or delete their data.
The regulation heavily emphasizes consent, requiring organizations to obtain explicit permission from individuals before processing their data.
One of the lesser-known aspects of GDPR is its focus on “data minimization,” which mandates that organizations only collect strictly necessary data for their operations.
This principle forces companies to rethink their data collection strategies, often leading to significant changes in how they interact with consumers.
HIPAA Overview
The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 in the United States.
Its primary purpose is to protect the privacy and security of individuals’ health information, commonly called Protected Health Information (PHI).
HIPAA applies to healthcare providers, health plans, clearing houses, and business associates.
HIPAA’s objectives include ensuring that an individual’s health information is adequately protected while allowing the flow of health data necessary to provide high-quality healthcare.
It introduces standards for handling PHI, covering everything from the use and disclosure of health information to the technical safeguards required to protect this data.
Unlike GDPR, which covers a wide range of personal data, HIPAA specifically focuses on health-related information.
This narrow focus allows for deep, specialized regulations that address the unique challenges of the healthcare industry.
One exciting aspect of HIPAA is its inclusion of the “minimum necessary” rule, similar to GDPR’s data minimization principle, which requires that only the minimum amount of PHI necessary for a given purpose be used or disclosed.
Key Similarities Between GDPR and HIPAA
Given their different origins and scopes, it might seem that GDPR and HIPAA would have little in common.
However, the correlation between GDPR and HIPAA becomes apparent when examining their shared goals of protecting sensitive data, ensuring accountability, and mandating breach notifications.
1. Data Protection and Privacy
At their core, GDPR and HIPAA are designed to protect individuals’ data, though they apply to different types of information.
GDPR protects a broad range of personal data, from names and email addresses to more sensitive information like biometric data.
However, HIPAA is focused exclusively on PHI, which includes any information that can be used to identify a patient and relates to their health status, healthcare provision, or payment for healthcare.
Both regulations recognize the fundamental right of individuals to have their data protected and provide mechanisms for individuals to exercise control over their information.
GDPR grants individuals several rights, such as the right to access their data, correct inaccuracies, and request the deletion of their data—a process known as the “right to be forgotten.”
HIPAA also grants individuals the right to access their health records and request corrections to their PHI.
One lesser-known similarity is that GDPR and HIPAA require organizations to conduct regular risk assessments to identify potential vulnerabilities in their data protection strategies.
This proactive approach is critical in ensuring organizations remain vigilant in the face of evolving threats.
2. Accountability and Compliance
GDPR and HIPAA impose strict accountability requirements on organizations that handle sensitive data.
Under GDPR, data controllers and processors must maintain detailed records of their data processing activities, demonstrate compliance with the regulation, and sometimes appoint a Data Protection Officer (DPO).
Similarly, HIPAA requires covered entities and business associates to implement comprehensive compliance programs, including appointing a Privacy Officer and a Security Officer.
One of the more complex aspects of compliance with GDPR and HIPAA is the need for organizations to demonstrate their adherence to the regulations.
This goes beyond simply having policies in place; organizations must be able to provide evidence that they are actively monitoring and enforcing these policies.
For instance, both regulations require organizations to implement technical and organizational measures to protect data, and failure to do so can result in severe penalties.
While it is commonly known that GDPR and HIPAA require documentation of compliance efforts, many organizations overlook the importance of regularly updating these documents.
As business processes and technologies evolve, so should the documentation of compliance measures.
Regular audits and updates to compliance documentation are essential in ensuring ongoing adherence to GDPR and HIPAA.
3. Breach Notification
Data breaches have become an unfortunate reality in today’s digital landscape, making breach notification requirements a critical component of GDPR and HIPAA.
Under GDPR, organizations must report a data breach to the relevant supervisory authority within 72 hours of becoming aware of it unless the breach is unlikely to risk individuals’ rights and freedoms.
Similarly, HIPAA requires covered entities to notify affected individuals, the U.S. Department of Health and Human Services (HHS), and, in some cases, the media within 60 days of discovering a breach of unsecured PHI.
The tight timeline is one of the most significant challenges in meeting these breach notification requirements.
Organizations must have robust incident response plans to assess a breach’s severity quickly, determine the appropriate course of action, and communicate with affected parties.
Failure to meet these requirements can result in substantial fines and damage an organization’s reputation.
The correlation between GDPR and HIPAA in breach notification extends beyond the legal requirements.
Both regulations emphasize the importance of transparency and maintaining trust with individuals.
Organizations that go above and beyond in their breach notification efforts—such as by offering credit monitoring services to affected individuals or providing regular updates on remediation efforts—can mitigate the negative impact of a breach and demonstrate their commitment to data protection.
Significant Differences Between GDPR and HIPAA
While there are apparent similarities between GDPR and HIPAA, it is equally important to understand the differences that set these regulations apart.
These differences can have significant implications for organizations that must comply with both rules.
1. Scope and Application
One of the most fundamental differences between GDPR and HIPAA is their scope and application.
GDPR has a broad, global reach, applying to any organization that processes the personal data of individuals in the EU, regardless of where the organization is based.
This extraterritorial scope means that even companies with no physical presence in the EU can be subject to GDPR if they offer goods or services to EU residents or monitor their behavior.
HIPAA, by contrast, is limited to the United States and specifically targets the healthcare sector.
It applies to “covered entities,” which include healthcare providers, health plans, and healthcare clearinghouses, as well as their “business associates,” which are third-party organizations that handle PHI on behalf of covered entities.
The differing scopes of these regulations mean that organizations operating in multiple jurisdictions need to consider which regulations apply to their operations carefully.
For example, a U.S.-based healthcare provider treating EU patients may need to comply with HIPAA and GDPR.
2. Data Subjects and Covered Entities
Another critical difference between GDPR and HIPAA lies in their focus on different types of data subjects and covered entities.
GDPR is concerned with protecting personal data, including anything from a person’s name and email address to more sensitive information like genetic data or political opinions.
The regulation applies to data controllers and processors, organizations that determine the purposes and means of processing personal data or processing data on behalf of controllers.
However, HIPAA is focused explicitly on PHI, which refers to any information that can be used to identify a patient and relates to their health condition, healthcare provision, or payment for healthcare services.
HIPAA applies to covered entities and their business associates, who must comply with HIPAA’s Privacy and Security Rules.
This distinction is critical for organizations that handle different types of data.
While a company may be primarily concerned with complying with HIPAA when handling PHI, it must also consider GDPR’s broader requirements if it processes other types of personal data, mainly if that data belongs to EU residents.
3. Consent and Legal Basis for Data Processing
GDPR and HIPAA also differ significantly in their approaches to consent and the legal basis for data processing.
Under GDPR, obtaining explicit consent from data subjects is one of several legal bases for processing personal data.
Consent must be freely given, specific, informed, and unambiguous, with data subjects having the right to withdraw their consent at any time.
Additionally, GDPR requires organizations to keep records of consent and provide individuals with clear and accessible information about how their data will be used.
In contrast, HIPAA’s approach to consent is more prescriptive and specific to PHI.
HIPAA generally allows covered entities to use or disclose PHI without patient consent for treatment, payment, and healthcare operations (TPO).
However, for uses and disclosures not covered by TPO, such as marketing activities or sharing PHI with third parties, HIPAA requires covered entities to obtain authorization, a more formalized version of consent.
This difference can create challenges for organizations that must comply with both regulations, as they may need to navigate different requirements for obtaining and documenting consent depending on the data type and the processing purpose.
4. Penalties and Enforcement
The penalties for non-compliance with GDPR and HIPAA are another area where the two regulations differ significantly.
GDPR is known for its severe fines, reaching up to €20 million or 4% of an organization’s global annual revenue, whichever is higher.
These fines are intended to be a deterrent and are imposed based on the severity of the violation, the organization’s size, and the impact on data subjects.
HIPAA also imposes penalties for non-compliance, but these are generally less severe than those under GDPR.
HIPAA fines are tiered based on negligence, with maximum penalties reaching $1.5 million per violation category per year.
However, HIPAA enforcement actions often focus on corrective measures, with organizations being required to implement remediation plans and pay fines.
One insider detail worth noting is that while GDPR’s fines are often seen as more punitive, HIPAA’s enforcement actions can be just as impactful due to the reputational damage and operational disruptions caused by mandatory corrective actions.
Organizations should not assume that HIPAA compliance is less critical simply because the financial penalties may be lower.
Practical Considerations for Compliance
For organizations subject to GDPR and HIPAA, navigating the complexities of dual compliance can be daunting.
However, with careful planning and a strategic approach, it is possible to achieve compliance with both regulations while minimizing operational disruptions.
1. Implementing a Dual Compliance Strategy
The first step in developing a dual compliance strategy is to conduct a comprehensive risk assessment that considers the requirements of both GDPR and HIPAA.
This assessment should identify potential gaps in existing data protection practices and prioritize areas for improvement.
One practical approach to dual compliance is harmonizing data protection practices where possible.
For example, organizations can adopt GDPR’s stringent consent requirements as a baseline for all data processing activities, ensuring they meet GDPR and HIPAA standards.
Similarly, robust encryption and access controls can help organizations comply with both regulations’ security requirements.
Another critical consideration is the appointment of compliance officers who are well-versed in both GDPR and HIPAA.
These officers can provide valuable guidance on navigating the complexities of dual compliance and ensure that the organization’s data protection practices are aligned with both sets of regulations.
2. Cross-Border Data Transfers
Cross-border data transfers present unique challenges for organizations subject to both GDPR and HIPAA.
GDPR imposes strict rules on international data transfers, requiring organizations to implement appropriate safeguards, such as Standard Contractual Clauses (SCCs) or Binding Corporate Rules (BCRs), to ensure that personal data is adequately protected when transferred outside the EU.
HIPAA, on the other hand, does not explicitly regulate international data transfers. However, organizations must ensure that any PHI transferred outside the U.S. is still protected by HIPAA’s requirements.
This may involve entering into Business Associate Agreements (BAAs) with foreign partners and ensuring that these partners comply with HIPAA’s Privacy and Security Rules.
Organizations that engage in cross-border data transfers should also consider the potential impact of data localization laws, which may require certain types of data to be stored within specific jurisdictions.
Navigating these requirements can be complex, but failure to do so can result in significant legal and financial consequences.
Conclusion
The correlation between GDPR and HIPAA is critical for any organization that handles sensitive data, particularly in the healthcare sector.
While these regulations share common goals and principles, their differences present unique challenges that require careful navigation.
By understanding these similarities and differences and by implementing robust compliance strategies, organizations can protect the privacy and security of individuals’ data while minimizing the risk of regulatory penalties.
As the regulatory landscape evolves, staying vigilant and proactive in compliance efforts is essential.
Whether through regular audits, continuous training, or adopting advanced compliance technologies, businesses prioritizing data protection will be better positioned to succeed in an increasingly complex and interconnected world.
To navigate these complexities confidently, contact Sertainty today to see how our data privacy tool can help your organization achieve GDPR and HIPAA compliance while safeguarding your sensitive data.
FAQs
Who is the General Data Protection Regulation applicable to?
The GDPR is applicable to any organization that processes personal data of individuals located within the European Union, regardless of where the organization is based.
Who do the data protection regulations apply to?
Data protection regulations, including the GDPR, apply to organizations that collect, process, or store personal data, ensuring the protection of individuals’ privacy and rights.
Who does the General Data Protection Regulation cover?
The GDPR covers individuals within the European Union, ensuring their personal data is protected by organizations that handle or process such information.
Who must comply with GDPR?
Organizations, both inside and outside the EU, that process the personal data of EU residents must comply with the GDPR, regardless of the organization’s geographic location.